Polyphor announces enrollment of first patient in Phase III clinical trial for murepavadin
EQS Group-News: Polyphor AG / Key word(s): Study
Allschwil, Switzerland, March 27th, 2018
Potentially first new class of antibiotics in Phase III development against Gram-negative pathogens in 50 years
Polyphor today announced the enrollment of the first patient in its PRISM-MDR European Phase III clinical trial for murepavadin (POL7080) for the treatment of ventilator-associated bacterial pneumonia (VABP) due to Pseudomonas aeruginosa.
Among the Gram-negative bacteria, Pseudomonas aeruginosa is one of the most dangerous bacteria. It is responsible for approximately 10% of all hospital-acquired infections and the second-leading cause of nosocomial pneumonia, with mortality rates of approximately 30-40%. Its strain that is resistant against the widely used antibiotic carbapenem has been classified as one of the top three critical pathogens by the World Health Organization (WHO).
Murepavadin is the lead compound in Polyphor's new class of antibiotics, the Outer Membrane Protein Targeting Antibiotics (OMPTA), which are potentially the first new class of antibiotics against Gram-negative bacteria to reach Phase III clinical development in more than 50 years. In contrast to commonly used broad-spectrum antibiotics, murepavadin is a pathogen specific antibiotic with a novel mechanism of action against which pathogens may only slowly build resistance.
Ignacio Martin-Loeches, Research Director of the Multidisciplinary Intensive Care Research Organization (MICRO) at Trinity College, Dublin, Ireland and Chairman of the Murepavadin PRISM program commented, "The treatment of HABP/VABP caused by Pseudomonas aeruginosa is becoming more challenging and new therapeutic options are desperately needed. The very potent and extensive coverage of murepavadin positions it well where there are risk factors associated with Multi Drug Resistant Pseudomonas aeruginosa nosocomial pneumonia as well as in stewardship programs where the de-escalation of broad spectrum agents is warranted after availability of susceptibility data."
"We believe murepavadin may lead to a paradigm shift in the treatment of nosocomial pneumonia due to Pseudomonas aeruginosa and become the standard of care in the treatment of patients with confirmed nosocomial pneumonia due to multidrug resistant and extensively drug-resistant strains," said Dr. Debra Barker, Chief Medical and Development Officer of Polyphor. "Our Phase II study showed promising results and, following discussions with both the FDA and EMA, we have agreed a streamlined development pathway towards completion of Phase III clinical development for murepavadin. The enrollment of the first patient in our European trial is a significant step towards bringing forward this new treatment option."
The study was designed based on feedback from the European Medicines Agency (EMA) and is agreed as the basis for a potential approval in the EU. The primary efficacy objective of the study is to assess the clinical cure rate at TOC in the mITT population. Eligible subjects with a high probability of VABP due to Pseudomonas aeruginosa will be randomized in a 2:1 ratio. The miTT population shall comprise 120 evaluable subjects (80 in the treatment arm) with VABP confirmed to be due to Pseudomonas aeruginosa.
Murepavadin is a pathogen specific antibiotic functioning through a novel mechanism of action involving binding to an outer membrane protein of Pseudomonas aeruginosa. In contrast to commonly used broad-spectrum antibiotics, murepavadin is a precision medicine and as such it supports the growing practice known as "antibiotic stewardship" which, among other things, seeks to reduce the excessive use of broad-spectrum products to avoid the buildup of resistance and to preserve the microbiome of the patients.
Based on promising Phase II results, Polyphor has agreed on a streamlined development pathway for murepavadin with the FDA and EMA and has started its first Phase III clinical trial.
Document: Polyphor_Murepavadin_First Patient